Cancers, PainPhase 3NCT00458510
Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
A Phase 3 study testing Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Cancers, Pain, run by Archimedes Development Ltd.
Trial summary
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancers, Pain
- What is being tested?
- Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give consent
- Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
- Diagnosis of cancer
- Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
- Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
- Able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
- Able to be up and about for 50% of the day or greater
Who cannot join
- Intolerance to opioids or fentanyl
- rapidly increasing/uncontrolled pain
- pain that is not cancer related
About this study
Official title: An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.
Read the detailed description
Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.
This study will examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.
After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.
- Conditions
- Cancers, Pain
- Being tested
- Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Keywords
- Pain, Cancer, Breakthrough
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Drug
Also called FCNS
treatment of up to 4 episodes of pain per day
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl, Open-Label treatment | Experimental | All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day Receives: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term Safety, tolerability and acceptability
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancers, PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archimedes Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell K Portenoy, MD, Principal investigator, Beth Israel Medical Center, New York, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458510
- Sponsor's protocol ID
- CPO45/06/FCNS
- Status last verified
- Jul 2013
- First submitted
- 10 Apr 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor D, Radbruch L, Revnic J, Torres LM, Ellershaw JE, Perelman MS. Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer [abstract]. J Clin Oncol. 2013:31(15 Suppl);9563
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy
- ClinicalTrials.gov ID
- NCT00458510
- Acronym / sponsor ID
- CPO45/06/FCNS
- Conditions
- Cancers, Pain
- Keywords
- Pain, Cancer, Breakthrough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Archimedes Development LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.
Detailed description
Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.
This study will examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.
After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl, Open-Label treatment | Experimental | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to give consent
- Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
- Diagnosis of cancer
- Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
- Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
Key exclusion criteria (3 listed)
- Intolerance to opioids or fentanyl
- rapidly increasing/uncontrolled pain
- pain that is not cancer related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Also: FCNStreatment of up to 4 episodes of pain per day | Drug | Fentanyl, Open-Label treatment |
Primary outcome
Long term Safety, tolerability and acceptability
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- Results publicationTaylor D, Radbruch L, Revnic J, Torres LM, Ellershaw JE, Perelman MS. Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer [abstract]. J Clin Oncol. 2013:31(15 Suppl);9563
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell K Portenoy, MD principal investigator
Beth Israel Medical Center, New York, United States
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Cancers, Pain, run by Archimedes Development Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term Safety, tolerability and acceptability (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.